Lenalidomide and Obinutuzumab for Previously Untreated CLL

Inclusion Criteria

• •1. Clinical and phenotypic verification of B cell CLL or SLL and measurable disease.
• •2. Prior therapy: no prior CLL therapy.
• •3. Patients must have progressive disease based on 2008 iwCLL definition with one of the following:
• •Symptomatic or progressive splenomegaly
• •Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy
• •Progressive anemia (hemoglobin ≤ 11 g/dL)
• •Progressive thrombocytopenia (platelets ≤ 100 x 109/L)
• •Weight loss \> 10% body weight over the preceding 6 month period
• •Fatigue attributable to CLL
• •Fever or night sweats for \> 2 weeks without evidence of infection
• •Progressive lymphocytosis with an increase of \> 50% over a 2-month period or an anticipated doubling time of less than 6 months.
• •Able to take aspirin (81mg or 325mg) daily, warfarin, low molecular weight heparin, or equivalent anticoagulation as prophylactic medication.
• •All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of REMS.
• •Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to starting Revlimid and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
• •Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program.
• •ECOG performance status of 0-2.
• •Adequate hematologic function
• •Adequate renal function
• •Adequate hepatic function